The background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided in this application is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
Quality control is a major issue in the diagnostic and laboratory testing industry, where accuracy of results is paramount to not only the efficacy of diagnostic and treatment procedures, but also to patient health. In addition to confounding results, poor sample quality can cost laboratories and researchers significantly in terms of time and money.
There are many factors that can influence sample quality. For example, mistakes or differences in the collection, storage, or preparation of biological samples can cause a sample to significantly change before it is analyzed. For example, differences in storage containers, temperature, reagents used, etc. can be detrimental to sample quality.
One solution to sample quality issues has been to increase rigor applied to pre-measurement protocols. For example, Ellervik and Vaught, in a 2015 Review Article entitled, “Preanalytical Variables Affecting the Integrity of Human Biospecimens in Biobanking,” Clinical Chemistry 61:7 914-934 (2015), identify that pre-measurement errors account for most errors in clinical laboratory results. They propose that laboratory personnel increase the rigor of protocols and documentation surrounding pre-measurement collection and handling of biological samples as a solution for limiting diminished sample quality.
But from a practical perspective there are many situations, particularly for a commercial laboratory, where the sample history (regarding collection, handling, and preparation) is unknown, or where obtaining a higher quality sample is not possible. In these situations, additional or alternative methods must be used to determine sample quality.
U.S. Pat. No. 5,846,492 to Jacobs et al. describes a spectrophotometric method for determining sample quality measurement in the dispensing tip of an analyzer. In this method, once a patient sample is aspirated into a pipette tip, the tip can be scanned in a light-tight enclosure that will analyze the absorbance spectra of the liquid. There are many potential limitations with this approach, but notably this reference fails to appreciate advances in technology that facilitate new ways of determining sample quality.
These and all other extrinsic materials discussed in this application are incorporated by reference in their entirety. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided in this application, the definition of that term provided in this application applies and the definition of that term in the reference does not apply.
Thus, there is still a need for improved systems and methods that enable determination of biological sample quality when sample history is unknown and without requiring additional equipment.